[Federal Register Volume 86, Number 157 (Wednesday, August 18, 2021)]
[Rules and Regulations]
[Pages 46156-46159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17682]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0118; FRL-8653-01-OCSPP]
Fluensulfone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerance for residues of
fluensulfone in or on soybean, seed. Makhteshim Agan of North America
(d/b/a ADAMA) requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 18, 2021. Objections and
requests for hearings must be received on or before October 18, 2021,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0118, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
[[Page 46157]]
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2020-0118 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
October 18, 2021. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0118, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of April 15, 2020 (85 FR 20910) (FRL-10006-
54), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petition (PP
9F8799) by Makhteshim Agan of North America (d/b/a ADAMA), 3120
Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition requested
that 40 CFR 180.680 be amended by establishing tolerances for residues
of the nematicide fluensulfone, in or on soybean, seed at 0.1 parts per
million (ppm); soybean, forage at 7.0 ppm; and soybean, hay at 20 ppm.
That document referenced a summary of the petition prepared by
Makhteshim Agan of North America, the petitioner, which is available in
the docket, http://www.regulations.gov. Two comments were received on
the notice of filing. EPA's response to these comments is discussed in
Unit IV.C.
Based upon review of the data supporting the petition, EPA is
establishing a tolerance that varies from what is requested. The reason
for these changes is explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for fluensulfone, including exposure resulting from
the tolerance established by this action. EPA's assessment of exposures
and risks associated with fluensulfone follows.
In an effort to streamline Federal Register publications, EPA is
not reprinting here summaries of its analyses that have previously
appeared in the Federal Register in previous tolerance rulemakings for
the same pesticide. To that end, this rulemaking refers the reader to
several sections from the April 13, 2018 tolerance rulemaking for
residues of fluensulfone that remain unchanged for an understanding of
the Agency's rationale in support of this rulemaking. See 83 FR 15971
(FRL-9975-76). Those sections are: Units III.A (Toxicological Profile);
III.B. (Toxicological Points of Departure/Levels of Concern); and
III.C. (Exposure Assessment), except as explained in the next
paragraphs; III.D. (Safety Factor for Infants and Children).
Exposure assessment updates. EPA's exposure assessments have been
updated to include the additional exposure from use of fluensulfone on
soybeans. EPA's aggregate exposure assessment incorporated this
additional dietary exposure, as well as exposure from drinking water
and from residential sources. The new use does not result in an
increase in the estimated residue levels in drinking water or in
exposure from residential sources relative to those used in the last
assessment.
Further information about EPA's risk assessment and determination
of safety supporting the new fluensulfone tolerance can be found at
http://www.regulations.gov in the document titled ``Fluensulfone. Human
Health Risk Assessment for a New Use on Soybean.'' in docket ID EPA-HQ-
OPP-2020-0118.
Assessment of aggregate risks. EPA determines whether acute and
chronic dietary pesticide exposures are safe by comparing aggregate
exposure estimates to the acute population adjusted dose (aPAD) and
chronic population adjusted dose (cPAD). Short-, intermediate-, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the appropriate points of
departure (PODs) to ensure that an adequate margin of exposure (MOE)
exists. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Acute dietary risks are below the Agency's level of concern: The
acute dietary risk estimate is 21% of the aPAD for infants (<1 year
old), the group with the highest exposure. Chronic dietary risks are
below the Agency's level of concern: 4.8% of the cPAD for infants (<1
year old), the group with the highest
[[Page 46158]]
exposure. EPA has concluded the combined short-term food, water, and
residential exposures result in aggregate margins of exposure above the
level of concern of 100 for all scenarios assessed and are not of
concern. EPA has determined that quantification of cancer risk using a
non-linear approach (i.e., reference dose) will adequately account for
all chronic toxicity, including carcinogenicity, that could result from
exposure to fluensulfone; the chronic aggregate assessment did not
result in risk estimates of concern.
Determination of safety. Therefore, based on the risk assessments
and information described above, EPA concludes there is a reasonable
certainty that no harm will result to the general population, or to
infants and children, from aggregate exposure to fluensulfone residues.
More detailed information on this action to establish a tolerance on
soybean can be found in the document entitled, ``Fluensulfone. Human
Health Risk Assessment for a new use on Soybean'' by going to the
docket established by this action, which is described under ADDRESSES.
IV. Other Considerations
A. Analytical Enforcement Methodology
There are adequate residue analytical methods for enforcing
tolerances for fluensulfone residues of concern in/on the registered
plant and livestock commodities. These methods include two high-
performance liquid chromatography methods with tandem mass-spectroscopy
detection (HPLC/MS/MS) for determining residues in/on plant and
livestock matrices.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for fluensulfone on soybean.
C. Response to Comments
EPA received two comments from anonymous sources. One comment cited
concern regarding fluoride; this comment is not relevant to the
Agency's evaluation of a tolerance for the proposed new use of
fluensulfone on soybean. The other comment expresses concern about
pesticides in general, and requests that the Agency deny use of
fluensulfone without specifically mentioning the new use on soybean.
While the agency recognizes that some people do not like pesticides,
the Agency has evaluated the aggregate risk of fluensulfone and has
determined that there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to fluensulfone residues.
D. Revisions to Petitioned-For Tolerances
The agency has determined that tolerances are not needed for
soybean, forage and soybean, hay, as the label contains a feeding
restriction for those commodities, and the commodities will not be in
the channels of trade. Further, the agency has recommended amending the
proposed tolerance for soybean, seed from 0.1 ppm to 0.07 ppm based
upon the OECD MRL/Tolerance Calculation Procedures.
V. Conclusion
Therefore, a tolerance is established for residues of fluensulfone
on soybean, seed at 0.07 ppm.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 46159]]
Dated: August 6, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.680, amend the table 1 to Sec. 180.680 by adding in
alphabetical order in paragraph (a) the entry ``Soybean, seed'' to read
as follows:
Sec. 180.680 Fluensulfone; tolerances for residues.
(a) * * *
Table 1 to Sec. 180.680
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * * *
Soybean, seed............................................. 0.07
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2021-17682 Filed 8-17-21; 8:45 am]
BILLING CODE 6560-50-P